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NCT01162499 · ClinicalTrials.gov registry record · NA
Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia
A NA study, sponsored by Diva De Leon.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT01162499: Completed NA study, sponsored by Diva De Leon.
NCT01162499 is a NA study that has completed, run by Diva De Leon. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01162499, a NA study, has completed, sponsored by Diva De Leon.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
It has been proposed that the rapid gastric emptying of carbohydrate containing fluids into the intestine causes hyperglycemia followed by reactive hypoglycemia. The investigators have shown that glucagon-like peptide-1 (GLP-1) secretion in response to a glucose load is increased in children with Post-prandial hypoglycemia (PPH). This is a proof of concept study to investigate the causative role of GLP-1 in the pathophysiology of PPH after fundoplication by evaluating the effects of GLP-1 receptor antagonism on metabolic variables after a mixed meal. Hypothesis: In children with post-prandial hypoglycemia after fundoplication, antagonism of the GLP-1 receptor by exendin-(9-39) will elevate nadir blood glucose levels after a meal challenge and prevent post-prandial hypoglycemia.
Primary Outcome
To examine the effect of Exendin-(9-39) on plasma glucose levels samples were collected at various time points before and during the infusion \[Exendin-(9-39) or vehicle\] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated
Interventions
- OTHER Vehicle
- DRUG Exendin-(9-39)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-12 |
| Phase | NA |
What the finished NCT01162499 record still lists
NCT01162499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01162499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01162499 about?
NCT01162499 is a clinical study titled "Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia". It has been proposed that the rapid gastric emptying of carbohydrate containing fluids into the intestine causes hyperglycemia followed by reactive hypoglycemia. The investigators have shown that glucagon-like peptide-1 (GLP-1) secretion in response to a glucose load is increased in children with Po...
What is the current status of trial NCT01162499?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2010-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01162499?
The interventions under investigation include: Vehicle (OTHER), Exendin-(9-39) (DRUG).
Who is sponsoring clinical trial NCT01162499?
This trial is sponsored by Diva De Leon, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01162499's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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